LBIO
Lion Biotechnologies Receives Orphan Status for Melanoma Treatment
1 hour 2 minutes ago - DJNF
By Cassandra Jaramillo
Lion Biotechnologies Inc. (LBIO) said Wednesday the U.S Food and Drug Administration granted orphan drug designation status for its treatment of malignant melanoma.
The treatment, LN-144, is the California company's lead product candidate for the treatment of Stage 2b to Stage 4 malignant melanoma. The FDA grants orphan status to drugs treating rare medical diseases, or conditions that affect fewer than 200,000 people in the U.S.
Shares of Lion recently were up 2% to $10.72.
The company, which went public in February, is developing cancer immunotherapies based on tumor-infiltrating lymphocytes, a process also known as adoptive T-cell therapy.
The FDA designation makes Lion eligible for tax credits for clinical testing, exemption from a prescription-drug user fee and seven years of market exclusivity.
Chief Executive Elma Hawkins said in a news release that the designation also will provide benefits from a regulatory and commercial perspective.
Lion is on track to initiate a Phase 2 trial of the melanoma treatment for later this year, the company said.
